Discreet Wearable device for Continuous Real-time Monitoring of Alcohol

用于连续实时监测酒精浓度的谨慎可穿戴设备

• 批准号: 10872334
• 负责人: Farshad Tehrani
• 金额: $ 5万
• 依托单位: ACTIOX LLC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2024-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10872334
• 关键词: Alcohol consumption; Alcohols; Algorithms; Bacterial Artificial Chromosomes; Biosensor; Blood; Calibration; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chemicals; Clinic; Clinical Research; Custom; Data; Detection; Development; Devices; Drug Rehabilitation Centers; Electronics; Face; Feasibility Studies; Forensic Medicine; Goals; Government; Hospitals; Hour; In Vitro; Intercellular Fluid; Laboratories; Measures; Mission; Modification; National Institute on Alcohol Abuse and Alcoholism; Needles; Pain Free; Painless; Penetration; Phase; Reporting; Reproducibility; Research; Series; Signal Transduction; Skin; Small Business Innovation Research Grant; System; Time; United States; Visualization; Work; alcohol measurement; alcohol monitoring; alcohol related problem; alcohol response; alcohol use disorder; attributable mortality; biomaterial compatibility; commercialization; cost; design; disability; drug testing; human subject; innovative technologies; monitoring device; novel; operation; programs; prospective; prototype; public health relevance; real time monitoring; sensor; sensor technology; vapor; wearable device; wearable sensor technology; wireless; Alcohol consumption; Alcohols; Algorithms; Bacterial Artificial Chromosomes; Biosensor; Blood; Calibration; Cause of Death; Centers for Disease Control and Prevention (U.S.); Cessation of life; Chemicals; Clinic; Clinical Research; Custom; Data; Detection; Development; Devices; Drug Rehabilitation Centers; Electronics; Face; Feasibility Studies; Forensic Medicine; Goals; Government; Hospitals; Hour; In Vitro; Intercellular Fluid; Laboratories; Measures; Mission; Modification; National Institute on Alcohol Abuse and Alcoholism; Needles; Pain Free; Painless; Penetration; Phase; Reporting; Reproducibility; Research; Series; Signal Transduction; Skin; Small Business Innovation Research Grant; System; Time; United States; Visualization; Work; alcohol measurement; alcohol monitoring; alcohol related problem; alcohol response; alcohol use disorder; attributable mortality; biomaterial compatibility; commercialization; cost; design; disability; drug testing; human subject; innovative technologies; monitoring device; novel; operation; programs; prospective; prototype; public health relevance; real time monitoring; sensor; sensor technology; vapor; wearable device; wearable sensor technology; wireless

Abstract Excessive alcohol use remains a leading preventable cause of death and disability in the United States. According to the Centers for Disease Control and Prevention (CDC), an average of 95,158 alcohol-attributable deaths (261 deaths per day) is reported only in the United States, with associated annual costs of $249 billion. The goal of this project is to develop a wearable integrated device capable of continuously measuring, recording, and storing ISF alcohol levels in real-time without the need for external calibrations. The National Institute on Alcohol Abuse and Alcoholism (NIAAA) seeks a wearable alcohol monitoring device that can continuously measure real-time alcohol levels in the blood or interstitial fluid (ISF), and this proposal is highly aligned with the NIAAA’s mission. An accurate wearable alcohol sensor will serve useful purposes in different settings, including research programs, clinics, forensic applications, and consumer use to promote responsible alcohol consumption. The available transdermal alcohol monitoring devices, relying on alcohol detection in sweat or sweat vapor, face significant problems such as long lag times (up to several hours) and tend to be cumbersome. In this context, ActioX, LLC has developed a non-obtrusive wearable sensor platform to enable pain-free analysis few hundred microns under the skin, directly in the ISF. The novel sensing technology relies on a biocompatible array of microneedles, optimized for painless skin penetration, and thus to provide continuous access to constantly revitalizing ISF. This fully integrated wirelessly operated device is composed of two components of a reusable electronics and a disposable microneedle array, along with a successful demonstration of a custom- designed app for data capture and visualization. Our preliminary data using the prototype device showed successful real-time tracking of ISF alcohol in response to alcohol drinking episodes in multiple human subjects, with the results well correlated to those from a breathalyzer. This SBIR Fast-Track project will leverage this innovative technology to develop a discreet, real-time, continuous, and calibration-free continuous alcohol monitoring device toward prolonged on-body operations to enable more comprehensive and accurate clinical studies and allow efficient control and management of alcohol-related problems, including alcohol use disorder. Phase I constitutes in-vitro feasibility studies to find the best chemical modification strategy with optimal sensitivity, selectivity, reproducibility, and extended 3-days stability. We aim in Phase II to execute a series of clinical studies to develop a prospective calibration algorithm that can convert, in real time, the raw electrochemical sensor signals to BAC. The data gathered through this work will support FDA clearance, and subsequently, the commercialization of our real-time, continuous alcohol monitoring wearable system as a reliable and accurate device ready to be used by end users, including hospitals, drug rehabilitation centers, drug testing laboratories, government departments, and others.

抽象的 在美国，过量的饮酒仍然是可预防的死亡和残疾原因。 根据疾病控制与预防中心（CDC）的数据，平均可提供95,158次酒精饮料 仅在美国报告死亡人数（每天261例），相关年费用为2490亿美元。 该项目的目的是开发能够连续测量，记录， 并实时存储ISF酒精水平，而无需外部校准。国家研究所 酒精滥用和酒精中毒（NIAAA）寻求可穿戴的酒精监测装置，可以继续 测量血液或间质液（ISF）中的实时酒精水平，该建议与 NIAAA的使命。准确的可穿戴酒精传感器将在不同的环境中提供有用的目的，包括 研究计划，诊所，法医应用以及消费者用来促进负责任的酒精 消耗。可用的透皮酒精监测设备，依赖于汗水中的酒精检测或 出汗蒸气，面临重大问题，例如长时间时间（长达几个小时），并且往往很麻烦。 在这种情况下，Actiox，LLC已开发了一个非引人注目的可穿戴传感器平台，以实现无痛苦分析 皮肤下的几百微米，直接在ISF中。新颖的传感技术依赖于生物相容性 一系列微针，可针对无痛的皮肤穿透进行优化，因此可以连续进入 不断振兴ISF。这个完全集成的无线操作设备由两个组成 可重复使用的电子设备和一次性微针阵列，并成功地展示了定制的 设计用于数据捕获和可视化的应用程序。我们使用原型设备的初步数据 成功地实时跟踪ISF酒精，以响应多个人类受试者的酒精饮酒发作， 结果与Broadhalyzer的结果息息相关。这个SBIR快速轨道项目将利用这一点 创新技术以开发谨慎，实时，连续和无校准的连续酒精 监视延长体内操作的设备，以实现更全面和准确的临床 研究并允许对酒精有关的问题有效控制和管理，包括酒精使用障碍。 第一阶段构成了体外可行性研究，以找到最佳的化学修饰策略 灵敏度，选择性，繁殖和延长的3天稳定性。我们的目标是第二阶段执行一系列 临床研究以开发一种预期校准算法，该算法可以实时转换 电化学传感器信号到BAC。通过这项工作收集的数据将支持FDA清除率，以及 随后，我们的实时，连续酒精监测可穿戴系统的商业化是 可靠且准确的设备，可以用最终用户使用，包括医院，毒品康复中心，毒品 测试实验室，政府部门等。